Clinical lab supply backorders: what to do when a validated item is out

When a validated supply goes on backorder, look for the same item first: the same manufacturer and catalog number from another distributor authorized to sell it. A validated supply is one your tests are set up to use, such as the collection swab or transport medium named in a test’s instructions. If you switch to a device those instructions don’t name, your lab must establish the test’s performance before it reports patient results, and your lab director is responsible for that work.

Why the same item comes first

Under CLIA, your lab tests by following the manufacturer’s instructions. 42 CFR 493.1252. CMS says the rules don’t prescribe which swab or transport medium a lab uses, only that it follows those instructions. If a replacement device isn’t named there, the lab must establish performance specifications before reporting patient results, and the lab director is responsible for that study. CMS CLIA FAQs.

Establishing performance specifications covers accuracy, precision, analytical sensitivity and specificity, the reportable range, reference intervals and any other characteristic the test requires, as they apply to the test. 42 CFR 493.1253. The same manufacturer and catalog number from another source needs none of that work, because it’s the item your lab already uses.

Check whether it’s a shortage or one distributor

The FDA publishes a list of the device categories it has determined to be in shortage. FDA shortage list. If your item’s category is on it, other sources may be short too, so bring your lab director in early. If it isn’t, the backorder may be your distributor’s stock alone, and another authorized distributor may have the same catalog number. Ask the manufacturer which distributors carry it.

Send your distributor a request it can answer line by line:

Backorder update for order: ______
Item, manufacturer and catalog number: ______
Quantity and ordering unit: ______
We need it by: ______
Revised ship date, in writing: ______
Stock in other warehouses: ______
Expiration date on the stock you could ship: ______

If the backorder affects several sites, our guide to backorders across multiple locations covers who follows up for each one.

Example: a validated swab before a kit launch

In this illustrative example, a lab builds collection kits for a home-health brand. Two weeks before the brand’s kit launch, the lab’s usual distributor puts its validated nasal swab on backorder for five weeks. The lab needs 24 boxes. A second authorized distributor has the same manufacturer and catalog number for delivery before the kits are built:

• Usual order: 24 boxes × $62 = $1,488
• Second distributor: 24 boxes × $71 = $1,704, plus $45 freight = $1,749
• Difference: $261, freight included

The quote comparison checklist covers checking two quotes like these line by line. The lab director confirms that the manufacturer and catalog number match the validated swab. The operations manager approves the $261 difference. The original order is cancelled in writing before the replacement is placed, so the lab isn’t shipped and billed twice. When the swabs arrive, lab staff count the boxes, check their condition and check the lot’s expiration date against the lab’s own rule of at least 12 months.

If the second distributor had offered a different swab instead, the choice would have gone to the lab director as a validation decision, with its own timeline.

Check what arrives

Check more than the count. For nonwaived testing, CLIA bars using supplies that are past their expiration date, have deteriorated or are of substandard quality. It also requires labs to set storage conditions such as temperature, and to monitor and document them. 42 CFR 493.1250 and 493.1252. Compare the lot’s expiration date with what you need, look for damage and follow any storage instructions as soon as the delivery arrives. The lab supply receiving checklist covers each check and the records to keep.

If you fill a reagent kit order from two sources, keep each kit’s components together. The same rules bar interchanging components of reagent kits with different lot numbers unless the manufacturer allows it. 42 CFR 493.1252.

If the delivery is short or the invoice doesn’t match, check the invoice against the receipt.

If no source has the same item

Take the substitute to your lab director for a validation decision. Bring the test’s instructions, the substitute’s manufacturer and catalog number, and the date you need it by. If the lab adopts the substitute, patient results wait until the lab has established the test’s performance with it. CMS CLIA FAQs. Tell the people who depend on the supply, such as a brand launching kits or the doctors and clinics that order tests, what changes and when.

Validated supply backorder checklist

Where Manoa fits

Manoa finds the same item from other authorized sources, gets your approvals, confirms the cancellation in writing and places the order on your account. Your lab director decides what’s validated, and your staff check what arrives. Our purchasing examples include the same lab kit launch, from the lab director’s confirmation to the check at receipt.